Urinary catheters for draining the bladder through the urethra are commonly packaged in sterile and pre-lubricated condition in flexible containers or pouches. In some cases, the catheters are intended to be fully removed from such containers at the time of catheterization, whereas in others the containers and catheters may remain in communication with the containers then serving as urine-collecting pouches. Reference may be had to U.S. Pat. No. 3,854,483 (Powers), U.S. Pat. No. 5,226,530 (Golden), U.S. Pat. No. 3,934,721 (Juster et al), U.S. Pat. No. 6,004,305 (Hursman et al), U.S. Pat. No. 5,147,341 (Starke et al) and U.S. Pat. No. 6,053,905 (Daignault et al) as illustrative of the art.
Catheterization commonly involves inserting the distal tip of a catheter (sometimes protected against contamination by an introducer sleeve as disclosed, for example, in U.S. Pat. Nos. 3,854,483 and 4,652,259) into the urethra and then longitudinally collapsing and extending the pouch in an accordion-like manner until the tip reaches the bladder. Such action is illustrated, for example, in U.S. Pat. No. 4,062,363 (Bonner). By gripping the remote (proximal) end of the catheter between the walls of the pouch during the pouch-collapsing phase, the catheter is advanced in a distal direction and, conversely, during the pouch-extending phase, the catheter is held against reverse sliding movement by gripping it between the pouch walls near the pouch""s distal end. The operation is a two-handed one requiring considerable dexterity to insure that the catheter is advanced during the pouch-collapsing phase and not retracted during the pouch-extending phase.
Complications may arise that make such a procedure even more difficult. For example, fluid pressure may tend to expel the catheter and require the user to continue gripping the catheter between the walls of the pouch to hold it in place during voiding. Because the catheter is lubricated, immobilizing it by applying a gripping force to the walls of the pouch may require more strength and dexterity than patients can provide, thereby precluding self-catheterization.
In an effort to reduce such problems, some packages for prelubricated catheters contain gripping devices that may be squeezed to help hold a catheter against reverse sliding movement (see U.S. Pat. Nos. 6,053,905, 6,004,305 and WO 98/06642). Typically, such gripping devices are designed to engage the side surfaces of a catheter but, since those surfaces are already lubricated, slippage may still readily occur.
Lubricating and gripping systems used in current catheter packages often have other shortcomings as well. Lubricant gel or liquid may not be retained in one area of such a package but may be free to migrate into the urine-collective chamber, causing the walls of the pouch to stick together and make voiding more difficult. Squeezable gripping devices, even if properly fitted onto the tip of a catheter during production, may slip off during storage and transport, requiring a user to refit such a device prior to catheterization. Further, in some constructions, lubricant tends to be unevenly distributed over the surfaces of a catheter, causing patient discomfort and risking possible injury during catheterization.
This invention therefore concerns an improved self-lubricating catheter package, and particularly an improved lubricator therefor, that overcome or at least greatly reduce the aforementioned defects and disadvantages of current products. More specifically, this invention involves a catheter package in which a flowable lubricant (preferably in the form of a gel) is retained in a guide housing located within the distal end of the pouch. Means are provided to ensure even distribution of the lubricant over the surfaces of a catheter during a catheterization procedure. The guide housing is formed of deformable and shape-recoverable material and has at its proximal end a frusto-conical wall or collar that grips unlubricated surface portions of a catheter and prevents unintentional sliding movement of the catheter during a catheterization procedure. More specifically, the tensioned collar restrains the catheter against longitudinal sliding movement until such time as an axial force is applied to the catheter that exceeds a selected threshold value. In addition to restraining unintended movement of the catheter relative to the lubricant housing, the collar effectively prevents the leakage of lubricant from the housing into the pouch.
The pouch is preferably flat and may serve as a urine-receiving container as well as a protective covering for maintaining the catheter in sterile condition prior to use. Preferably, but not necessarily, the walls of the pouch are sufficiently transparent so that the guide housing is visible through the walls of the pouch. The housing has a distal end portion of generally cylindrical configuration and a bulbous body portion, which at least in one embodiment is of oval cross section, extending between the housing""s proximal and distal end portions. Where an oval shape is provided, the housing is preferably secured within the pouch so that the major axis of the oval extends along a plane parallel with and interposed between the coplanar side walls of the pouch.
The housing""s distal end portion includes an end wall having an opening for advancement of a catheter therethrough during the catheterization procedure. In one embodiment of the invention, an integral introducer sleeve projects distally from the distal end wall and terminates in a rounded end having a multiplicity of crossed diametrically-extending slits defining a circumferential series of at least six, and preferably eight, radially-extending and inwardly-tapering flaps. In another embodiment, the introducer sleeve is omitted and a similar array of inwardly-extending flaps is formed instead in the distal end wall of the lubricant housing.
In each embodiment, the cylindrical distal end portion of the lubricant housing may have an internal series of circumferentially-spaced stiffening ribs. Such ribs are generally semi-conical in configuration and not only stiffen or rigidify the distal end portion of the lubricant housing but also help to direct the tip of a catheter towards the opening in the housing""s distal end and into the passageway of the introducer sleeve if the embodiment is equipped with such a sleeve. Of particular importance is the fact that the opening defined by the ribs, as well as the opening through the distal end wall and the passageway of the introducer sleeve, are all substantially greater in diameter than the outside diameter of the catheter to be advanced therethrough. As the catheter is so advanced, and as the body portion of the lubricant chamber is gripped between the walls of the pouch and is preferably squeezed not only to hold the assembly but also to cause the distal displacement of lubricant, the outer surfaces of the catheter receives an even coating of flowable lubricant material. Because of the relatively large size of the distal opening (and of the introducer passageway) and the multiplicity of flexible flaps, the lubricant that is applicable to the catheter remains evenly distributed on its surfaces as the catheter enters urethra.